Research & Development
Pfizer-BioNTech COVID-19 Vaccine Receives FDA Emergency Use Authorization for Children 6 Months through 4 Years of Age
17 June 2022 - - The US Food and Drug Administration granted emergency use authorization of the Pfizer-BioNTech COVID-19 Vaccine as a three 3-µg dose series for children 6 months through 4 years of age (also referred to as 6 months to less than 5 years of age), US-based pharmaceutical company Pfizer Inc. (NYSE: PFE) and German biotechnology company BioNTech SE (NASDAQ: BNTX) said.

The 3-µg dose was carefully selected as the preferred dose for children under 5 years of age based on safety, tolerability, and immunogenicity data.

The EUA is based on data from a Phase 2/3 randomized, controlled trial that included 4,526 children 6 months through 4 years of age.

In the trial, children received the third 3-µg dose at least two months after the second dose at a time when Omicron was the predominant variant.

Following a third dose in this age group, the vaccine was found to elicit a strong immune response, with a favorable safety profile similar to placebo.

In the trial, the SARS-CoV-2-neutralizing antibody geometric mean titer one month after the third dose was 1,535.2 (95% CI, 1,388.2, 1,697.8) in children 2 through 4 years of age and 1,406.5 (95% CI, 1,211.3, 1,633.1) in infants 6 through 23 months.

The antibody responses in both age groups were comparable to those recorded in people 16 to 25 years of age immunized with two 30-µg doses and met the pre-specified success criteria to declare non-inferiority.

Demonstration of noninferiority and safety were the regulatory requirements for potential authorization of the Pfizer-BioNTech COVID-19 Vaccine in this age group.

Three 3-µg doses of the Pfizer-BioNTech COVID-19 Vaccine demonstrated a favorable safety and tolerability profile comparable to placebo.

No new safety signals were identified, and the frequency of adverse reactions observed in children 6 months through 4 years were generally lower than in children 5 through 11 years.

In the 6 through 23 months age group, 30.3% of participants reported adverse events in the Pfizer-BioNTech COVID-19 Vaccine group, and 27.3% of participants reported adverse events in the placebo group.

Similarly, 18.8% and 18.9% of participants who received the Pfizer-BioNTech COVID-19 Vaccine or placebo respectively reported adverse events in the 2 through 4-year age group.

Reactogenicity events were mostly mild to moderate and short lived for both age groups with systemic events comparable to placebo. Reactions were comparable after dose 1, 2 and 3.

The clinical trial results were reviewed by the FDA Vaccines and Related Biological Products Advisory Committee (VRBPAC) on June 15, who unanimously recommended authorization.

The US Centers for Disease Control and Prevention's Advisory Committee on Immunization Practices will meet June 17 and June 18 to discuss a potential recommendation for the use and rollout of the vaccine to children 6 months through 4 years of age.

Vaccinations for children 6 months through 4 years of age are anticipated to start subject to and after the CDC endorses the ACIP recommendation.

Pfizer and BioNTech will begin shipping 3-µg pediatric doses as directed by the US government. Eligible US residents will continue to receive the vaccine for free, consistent with the US government's commitment to free access to COVID-19 vaccines.

The companies plan to submit requests for authorization of their COVID-19 vaccine in this age group to other regulators around the world, including the European Medicines Agency in early July.

The Pfizer-BioNTech COVID-19 Vaccine, which is based on BioNTech's proprietary mRNA technology, was developed by both BioNTech and Pfizer.

BioNTech is the Marketing Authorization Holder in the United States, the European Union, the United Kingdom, Canada and the holder of emergency use authorizations or equivalents in the United States (jointly with Pfizer) and other countries.

Submissions to pursue regulatory approvals in those countries where emergency use authorizations or equivalent were initially granted are planned.

The Phase 1/2/3 trial has enrolled more than 10,000 children ages 6 months to under 12 years of age in the United States, Finland, Poland, Spain and Brazil from more than 90 clinical trial sites.

The trial evaluated the safety, tolerability, and immunogenicity of the Pfizer-BioNTech COVID-19 Vaccine in three age groups: ages 5 to under 12 years; ages 2 to under 5 years; and ages 6 months to under 2 years.

Based on the Phase 1 dose-escalation portion of the trial, children ages 5 to under 12 years received a two-dose schedule of 10 µg each while children under age 5 received three lower 3-µg doses in the Phase 2/3 study. The trial enrolled children with or without prior evidence of SARS-CoV-2 infection.
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